Epigenetic Effects of a Single Bout of Exercise on Cardiovascular Risk Factors and the Metabolome

Sponsor
East Carolina University (Other)
Overall Status
Completed
CT.gov ID
NCT05034380
Collaborator
Purdue University (Other), Louisiana State University Health Sciences Center Shreveport (Other)
30
1
2
18
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Study Details

Study Description

Brief Summary

The purpose of this study is to determine the ability of acute exercise to regulate fat metabolism in muscle of overweight and obese people compared to lean people.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Acute exercise
N/A

Detailed Description

After being informed about the study details and possible risks and benefits, 15 overweight/obese and 15 lean participants gave written informed consent and were then screened and enrolled in the study. All participants then gave a muscle sample and ate a calorically controlled breakfast. Participants completed ~1 hour of cycling exercise on a stationary bike and gave a second muscle sample 4 hours after eating breakfast.

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
All participants underwent the same exact study protocol on random days throughout the study period.All participants underwent the same exact study protocol on random days throughout the study period.
Masking:
Single (Outcomes Assessor)
Masking Description:
Investigators conducting molecular analysis were blinded to study samples/groups.
Primary Purpose:
Basic Science
Official Title:
Epigenetic Effects of a Single Bout of Exercise on Cardiovascular Risk Factors and the Metabolome in Lean and Overweight or Obese Subjects
Actual Study Start Date :
Sep 14, 2014
Actual Primary Completion Date :
Oct 6, 2015
Actual Study Completion Date :
Mar 14, 2016

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Lean

males aged 18-30 years with BMI < 25

Behavioral: Acute exercise
All participants consumed a standardized, high carbohydrate meal (7 kcal/kg; 60% carbohydrate, 25% fat, 15% protein) and completed an exercise testing trial, expending a total of 650 kcal upon completion 4h later.

Experimental: Overweight/Obese

males aged 18-30 years with BMI >= 25

Behavioral: Acute exercise
All participants consumed a standardized, high carbohydrate meal (7 kcal/kg; 60% carbohydrate, 25% fat, 15% protein) and completed an exercise testing trial, expending a total of 650 kcal upon completion 4h later.

Outcome Measures

Primary Outcome Measures

  1. Change from baseline in skeletal muscle acylcarnitines [Baseline and immediately after acute cycling exercise]

    Metabolomics of skeletal muscle acylcarnitines is used as a measure of mitochondrial function by assessing long, medium and short chain acylcarnitine levels.

  2. Change from baseline in skeletal transcriptome [Baseline and immediately after acute cycling exercise]

    RNA-seq is a method used to quantify changes in all known messenger RNA levels in the genome, giving an assessment of whole genome gene transcription changes.

  3. Change from baseline in skeletal muscle whole genome nucleosome maps [Baseline and immediately after acute cycling exercise]

    MNase-seq is a method used to determine the occupancy/location of nucleosomes throughout the entire genome, supporting evidence of alterations in epigenetic modifications occurring at specific genomic loci that affect nucleosome occupancy/location and possibly gene transcription or silencing.

Secondary Outcome Measures

  1. Glucose [Baseline and immediately after acute cycling exercise]

    Commercially validated and available colorimetric used to determine plasma glucose levels.

  2. Insulin [Baseline and immediately after acute cycling exercise]

    Commercially validated and available ELISAs used to determine plasma insulin levels.

  3. Triglycerides [Baseline and immediately after acute cycling exercise]

    Commercially validated and available colorimetric kits used to determine plasma triglyceride levels.

  4. Free fatty acids [Baseline and immediately after acute cycling exercise]

    Commercially validated and available colorimetric kits used to determine plasma free fatty acid levels.

  5. Cholesterol [Baseline and immediately after acute cycling exercise]

    Commercially validated and available colorimetric kits used to determine total cholesterol, HDL, LDL and VLDL levels in plasma.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 30 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • healthy males that completed a physical examination with a State Licensed M.D. or D.O. within the past 2 years and completed a physical activity readiness questionnaire (PARQ), the International Physical Activity Questionnaires (IPAQ) and and a medical history questionnaire prior to the study
Exclusion Criteria:
  • any participants that had not had a physical examination by a State Licensed M.D. or D.O. within the past 2 years

  • persons not considered "healthy" (with any previous medical diagnoses) or not medically cleared by a M.D. or D.O. to perform physical activity/exercise

  • persons who are regularly physically active

Contacts and Locations

Locations

Site City State Country Postal Code
1 Purdue University West Lafayette Indiana United States 47907

Sponsors and Collaborators

  • East Carolina University
  • Purdue University
  • Louisiana State University Health Sciences Center Shreveport

Investigators

  • Principal Investigator: Tara Henagan, PhD, Purdue University, Louisiana State University Medical School at Shreveport

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jessica Ellis, Assistant Professor, East Carolina University
ClinicalTrials.gov Identifier:
NCT05034380
Other Study ID Numbers:
  • AcuteExerciseNucleo
First Posted:
Sep 5, 2021
Last Update Posted:
Sep 5, 2021
Last Verified:
Aug 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 5, 2021